CLE DE PEAU BEAUTE FOUNDATION I  BF20 - titanium dioxide cream 
CLE DE PEAU BEAUTE FOUNDATION I  I10 - titanium dioxide cream 
CLE DE PEAU BEAUTE FOUNDATION I  O10 - titanium dioxide cream 
CLE DE PEAU BEAUTE FOUNDATION I  O20 - titanium dioxide cream 
CLE DE PEAU BEAUTE FOUNDATION I  O30 - titanium dioxide cream 
CLE DE PEAU BEAUTE FOUNDATION I  B10 - titanium dioxide cream 
CLE DE PEAU BEAUTE FOUNDATION I  B20 - titanium dioxide cream 
CLE DE PEAU BEAUTE FOUNDATION I  B30 - titanium dioxide cream 
SHISEIDO CO., LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

Active ingredients

TITANIUM DIOXIDE 2.1%

Purpose

Sunscreen

Uses

Warnings

For external use only.

When using this product

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

  • rash or irritation develops and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

WATER, CYCLOMETHICONE, TALC, BUTYLENE GLYCOL, NYLON-12, DIMETHICONE, GLYCERIN, PEG-10 DIMETHICONE, DEXTRIN PALMITATE, BARIUM SULFATE, POLYMETHYL METHACRYLATE, TOCOPHERYL ACETATE, GINKGO BILOBA LEAF EXTRACT, SODIUM ACETYLATED HYALURONATE, ROSA ROXBURGHII FRUIT EXTRACT, LILIUM CANDIDUM BULB EXTRACT, ALUMINUM HYDROXIDE, PALMITIC ACID, STEARIC ACID, TRISODIUM EDTA, DISTEARYLDIMONIUM CHLORIDE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, POLYSILICONE-2, ISOPROPYL ALCOHOL, SYNTHETIC FLUORPHLOGOPITE, TOCOPHEROL, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE, PHENOXYETHANOL, FRAGRANCE, TITANIUM DIOXIDE, IRON OXIDES, MICA

Questions?

1-800-906-7503

Manufactured by
SHISEIDO CO., LTD.
7-5-5 GINZA TOKYO

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton (BF 20)

clé de peau
BEAUTÉ

cream foundation

SPF 26
sunscreen

25mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton (BF 20)

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton (I10)

clé de peau
BEAUTÉ

cream foundation

SPF 26
sunscreen

25mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton (I10)

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton (O10)

clé de peau
BEAUTÉ

cream foundation

SPF 26
sunscreen

25mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton (O10)

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton (O20)

clé de peau
BEAUTÉ

cream foundation

SPF 26
sunscreen

25mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton (O20)

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton (O30)

clé de peau
BEAUTÉ

cream foundation

SPF 26
sunscreen

25mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton (O30)

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton (B10)

clé de peau
BEAUTÉ

cream foundation

SPF 26
sunscreen

25mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton (B10)

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton (B20)

clé de peau
BEAUTÉ

cream foundation

SPF 26
sunscreen

25mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton (B20)

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton (B30)

clé de peau
BEAUTÉ

cream foundation

SPF 26
sunscreen

25mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton (B30)

CLE DE PEAU BEAUTE FOUNDATION I   BF20
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-338
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (Titanium dioxide) Titanium dioxide0.65625 g  in 31.25 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 
TALC 
BUTYLENE GLYCOL 
DIMETHICONE 
GLYCERIN 
BARIUM SULFATE 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
GINKGO 
ROSA ROXBURGHII FRUIT 
LILIUM CANDIDUM BULB 
ALUMINUM HYDROXIDE 
PALMITIC ACID 
STEARIC ACID 
EDETATE TRISODIUM 
DISTEARYLDIMONIUM CHLORIDE 
ISOPROPYL ALCOHOL 
ALPHA-TOCOPHEROL 
PHENOXYETHANOL 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
MICA 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:52685-338-601 TUBE ( TUBE) in 1 CARTONcontains a TUBE
131.25 g in 1 TUBEThis package is contained within the CARTON (52685-338-60)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2011

CLE DE PEAU BEAUTE FOUNDATION I   I10
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-339
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (Titanium dioxide) Titanium dioxide0.65625 g  in 31.25 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 
TALC 
BUTYLENE GLYCOL 
DIMETHICONE 
GLYCERIN 
BARIUM SULFATE 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
GINKGO 
ROSA ROXBURGHII FRUIT 
LILIUM CANDIDUM BULB 
ALUMINUM HYDROXIDE 
PALMITIC ACID 
STEARIC ACID 
EDETATE TRISODIUM 
DISTEARYLDIMONIUM CHLORIDE 
ISOPROPYL ALCOHOL 
ALPHA-TOCOPHEROL 
PHENOXYETHANOL 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
MICA 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:52685-339-601 TUBE ( TUBE) in 1 CARTONcontains a TUBE
131.25 g in 1 TUBEThis package is contained within the CARTON (52685-339-60)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2011

CLE DE PEAU BEAUTE FOUNDATION I   O10
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-340
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (Titanium dioxide) Titanium dioxide0.65625 g  in 31.25 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 
TALC 
BUTYLENE GLYCOL 
DIMETHICONE 
GLYCERIN 
BARIUM SULFATE 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
GINKGO 
ROSA ROXBURGHII FRUIT 
LILIUM CANDIDUM BULB 
ALUMINUM HYDROXIDE 
PALMITIC ACID 
STEARIC ACID 
EDETATE TRISODIUM 
DISTEARYLDIMONIUM CHLORIDE 
ISOPROPYL ALCOHOL 
ALPHA-TOCOPHEROL 
PHENOXYETHANOL 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
MICA 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:52685-340-601 TUBE ( TUBE) in 1 CARTONcontains a TUBE
131.25 g in 1 TUBEThis package is contained within the CARTON (52685-340-60)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2011

CLE DE PEAU BEAUTE FOUNDATION I   O20
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-341
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (Titanium dioxide) Titanium dioxide0.65625 g  in 31.25 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 
TALC 
BUTYLENE GLYCOL 
DIMETHICONE 
GLYCERIN 
BARIUM SULFATE 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
GINKGO 
ROSA ROXBURGHII FRUIT 
LILIUM CANDIDUM BULB 
ALUMINUM HYDROXIDE 
PALMITIC ACID 
STEARIC ACID 
EDETATE TRISODIUM 
DISTEARYLDIMONIUM CHLORIDE 
ISOPROPYL ALCOHOL 
ALPHA-TOCOPHEROL 
PHENOXYETHANOL 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
MICA 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:52685-341-601 TUBE ( TUBE) in 1 CARTONcontains a TUBE
131.25 g in 1 TUBEThis package is contained within the CARTON (52685-341-60)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2011

CLE DE PEAU BEAUTE FOUNDATION I   O30
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-342
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (Titanium dioxide) Titanium dioxide0.65625 g  in 31.25 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 
TALC 
BUTYLENE GLYCOL 
DIMETHICONE 
GLYCERIN 
BARIUM SULFATE 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
GINKGO 
ROSA ROXBURGHII FRUIT 
LILIUM CANDIDUM BULB 
ALUMINUM HYDROXIDE 
PALMITIC ACID 
STEARIC ACID 
EDETATE TRISODIUM 
DISTEARYLDIMONIUM CHLORIDE 
ISOPROPYL ALCOHOL 
ALPHA-TOCOPHEROL 
PHENOXYETHANOL 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
MICA 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:52685-342-601 TUBE ( TUBE) in 1 CARTONcontains a TUBE
131.25 g in 1 TUBEThis package is contained within the CARTON (52685-342-60)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2011

CLE DE PEAU BEAUTE FOUNDATION I   B10
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-343
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (Titanium dioxide) Titanium dioxide0.65625 g  in 31.25 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 
TALC 
BUTYLENE GLYCOL 
DIMETHICONE 
GLYCERIN 
BARIUM SULFATE 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
GINKGO 
ROSA ROXBURGHII FRUIT 
LILIUM CANDIDUM BULB 
ALUMINUM HYDROXIDE 
PALMITIC ACID 
STEARIC ACID 
EDETATE TRISODIUM 
DISTEARYLDIMONIUM CHLORIDE 
ISOPROPYL ALCOHOL 
ALPHA-TOCOPHEROL 
PHENOXYETHANOL 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
MICA 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:52685-343-601 TUBE ( TUBE) in 1 CARTONcontains a TUBE
131.25 g in 1 TUBEThis package is contained within the CARTON (52685-343-60)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2011

CLE DE PEAU BEAUTE FOUNDATION I   B20
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-344
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (Titanium dioxide) Titanium dioxide0.65625 g  in 31.25 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 
TALC 
BUTYLENE GLYCOL 
DIMETHICONE 
GLYCERIN 
BARIUM SULFATE 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
GINKGO 
ROSA ROXBURGHII FRUIT 
LILIUM CANDIDUM BULB 
ALUMINUM HYDROXIDE 
PALMITIC ACID 
STEARIC ACID 
EDETATE TRISODIUM 
DISTEARYLDIMONIUM CHLORIDE 
ISOPROPYL ALCOHOL 
ALPHA-TOCOPHEROL 
PHENOXYETHANOL 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
MICA 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:52685-344-601 TUBE ( TUBE) in 1 CARTONcontains a TUBE
131.25 g in 1 TUBEThis package is contained within the CARTON (52685-344-60)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2011

CLE DE PEAU BEAUTE FOUNDATION I   B30
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-345
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (Titanium dioxide) Titanium dioxide0.65625 g  in 31.25 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 
TALC 
BUTYLENE GLYCOL 
DIMETHICONE 
GLYCERIN 
BARIUM SULFATE 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
GINKGO 
ROSA ROXBURGHII FRUIT 
LILIUM CANDIDUM BULB 
ALUMINUM HYDROXIDE 
PALMITIC ACID 
STEARIC ACID 
EDETATE TRISODIUM 
DISTEARYLDIMONIUM CHLORIDE 
ISOPROPYL ALCOHOL 
ALPHA-TOCOPHEROL 
PHENOXYETHANOL 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
MICA 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:52685-345-601 TUBE ( TUBE) in 1 CARTONcontains a TUBE
131.25 g in 1 TUBEThis package is contained within the CARTON (52685-345-60)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2011

Labeler - SHISEIDO CO., LTD. (690536453)
Establishment
NameAddressID/FEIOperations
SHISEIDO CO., LTD.690536453MANUFACTURE, ANALYSIS

Revised: 07/2011 SHISEIDO CO., LTD.